Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Nobel Biocare | INDUSTRY |
Not provided
Not provided
Not provided
The purpose of this clinical controlled study is to compare anterior facial gingival level change between Immediate implant placement and provisionalization with bone graft and with socket shield technique.
Immediate implant placement and provisionalization, short for IIPP, is one of a very viable option for failing anterior teeth. It has been advocated with documented success for more than 20 years. Despite the decent results, the challenges remains on the altered of the facial implant tissue architecture. To avoid the facial contour change and the possible following esthetic problem, clinicians have tried several ways to preserve the contour, like bone grafting in the gap between the facial bone and implant, or enhance facial gingival tissue thickness through augmentation procedures.
The concept of retaining part of the root, or root shield in conjunction with IIPP was proposed around 8 to 9 years ago. So-called socket shield technique. It has claimed to have successfully preserve the facial contour. Animal studies and couple clinical studies have showed decent results.
The purpose of this clinical controlled study is to compare the facial gingival level change between IIPP with bone graft and with socket shield technique. There are two groups in this study, 13 patients each. Extrusion criteria including male under 21 years old, female under 23 years old, smoker, pregnant patient, history of head and neck radiation, soft tissue defect like inflammation, recession, active infection. On the control group, patient will received IIPP with bone graft; On the test group, IIPP and socket shield technique will be provided. All clinical examinations and data collections will be performed by one investorgator, who will do the measurement at presurgical appointment, Tps, the time of implant placement, Tm0, 6-months Tm6, and 12-months after implant placement Tm12. Data analysis will be blind. Intraexaminer reliability will be performed.
We are looking at 12 elements in this study. The main variable will be facial gingival level change. We will use Intraoral scanner and the 3D images obtained at different time point will be superimposed, to see if there is any significant change between two groups.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate implant placement and provisionalization | Experimental | On the control group, Implant will be placed immediately after tooth extraction. The gap between the implant and buccal bone will be filled with bone graft. Temporary crown will be attached to implant fixture. |
|
| Socket shield technique | Experimental | On the test group, Implant will be placed immediately after tooth extraction. A piece of root shield will be retained intentionally at facial side. Temporary crown will attached to implant fixture. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immediate implant placement and provisionalization | Procedure | Failing tooth will be extracted and immediate placed endosseous implant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Facial gingival level change | The baseline measurement will be compared with digital superimposition of intraoral scanned images at 12 months post-op | At baseline (pre-op) and at 12 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Soft tissue volume change | The baseline measurement will be compared with digital superimposition of intraoral scanned images at 12 months post-op | At baseline (pre-op) and 12 months after surgery |
Not provided
Inclusion Criteria:
Exclusion Criteria (control group)
Exclusion Criteria (test group)
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Joseph Kan, DDS | Loma Linda dental implant department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University school of dentistry | Loma Linda | California | 92350 | United States | ||
| Loma Linda University Health |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D057893 | Immediate Dental Implant Loading |
| ID | Term |
|---|---|
| D003758 | Dental Implantation, Endosseous |
| D003757 | Dental Implantation |
| D013516 | Oral Surgical Procedures, Preprosthetic |
| D019647 | Oral Surgical Procedures |
Not provided
Not provided
There are two groups in this study, 13 patients each. Subjects who fulfill the inclusion criteria with one failing anterior tooth will be included into this study.
Not provided
Not provided
Data analysis will be blind. Intraexaminer reliability will be performed.
|
| Loma Linda |
| California |
| 92354 |
| United States |
| D013514 | Surgical Procedures, Operative |
| D019919 | Prosthesis Implantation |
| D003813 | Dentistry |
| D011476 | Prosthodontics |